Screening Tests for Anal Cancer

(SWAN Trial)

Recruiting at 4 trial locations

Overseen By Daniela Solis

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Prior high resolution anoscopy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

300 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this single arm trial is to prospectively evaluate screening methods for anal cancer precursors in HIV uninfected women with a history of lower genital tract neoplasias and cancers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for anal cancer screening?

High-resolution anoscopy (HRA) is considered a valuable tool for screening anal dysplasia, especially in high-risk groups like HIV-positive individuals, as it helps identify precursors to anal cancer. Although there are no specific guidelines, its use is informed by similar techniques used for cervical dysplasia, suggesting its potential effectiveness in preventing anal cancer. ^{1 2 3 4 5}

Is high-resolution anoscopy (HRA) safe for humans?

The research does not provide specific safety data for high-resolution anoscopy (HRA), but it does mention patient tolerability and acceptability, suggesting it is generally well-tolerated by patients. ^{1 2 3 5 6}

How is the treatment for anal cancer screening different from other treatments?

The treatment for anal cancer screening using high-resolution anoscopy (HRA) is unique because it involves a detailed visual examination of the anal area using a special magnifying device, which helps identify precancerous changes early. Unlike other treatments, HRA is specifically designed for screening and monitoring high-risk patients, such as those with HIV, to prevent the progression to anal cancer. ^{1 2 5 6 7}

Research Team

Elizabeth Chiao, MD

Principal Investigator

M.D. Anderson Cancer Center

Keith Sigel, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Ashish Deshmukh, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for women under 45 years old who have had high-grade HPV-related diseases or non-metastatic cancers of the cervix, vagina, or vulva. They must be HIV-negative and treated within Mount Sinai Health System or Harris Health System in Houston. Participants need to understand English or Spanish.

Inclusion Criteria

I have had a high-grade HPV-related disease or non-spreading cancer in my genital area.

Seen in the Mount Sinai Health System (MSHS) or the Harris Health System (HHS) in Houston

I am 35 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo baseline evaluation including anal cytology, HPV testing, and high resolution anoscopy

1 visit

1 visit (in-person)

Follow-up Evaluation

Participants undergo follow-up evaluations to determine the incidence of anal high-grade squamous intraepithelial lesions and new hrHPV infections

24 months

2 visits (in-person) at 12 and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Diagnostic tests for anal cancer screening

Trial Overview The study is evaluating diagnostic tests used to screen for anal cancer precursors in women with a history of lower genital tract neoplasias and cancers but who do not have HIV.

Participant Groups

Group I: Women With Prior HPV for Anal Neoplasia Experimental Treatment 1 Intervention

Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy.

Diagnostic tests for anal cancer screening is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Anal Pap test for:

• Screening for anal cancer precursors in high-risk populations

Approved in European Union as Digital rectal exam for:

• Detection of anal cancer and anal dysplasia

Approved in Canada as Anoscopy for:

• Diagnosis and screening of anal cancer

Approved in United States as High resolution anoscopy (HRA) for:

• Detection and treatment of anal dysplasia and anal cancer

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Findings from Research

In a study of 91 high-risk patients undergoing high-resolution anoscopy (HRA), 30% were found to have high-grade dysplasia, highlighting the importance of screening in this population.

Patients presenting with anal pain or lesions were significantly more likely to have high-grade dysplasia, suggesting that these symptoms should prompt consideration for HRA screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Symptomatology in Anal Dysplasia. Hicks, CW., Wick, EC., Leeds, IL., et al.[2015]

A study involving 404 patients undergoing high resolution anoscopy (HRA) found that the median pain score was low (2 out of 10), indicating that the procedure is generally well-tolerated, although women reported higher pain levels than men.

Despite some experiencing higher pain, 76% of patients rated their satisfaction with the care received as a perfect 10, and 98% of women and 99% of men expressed willingness to undergo future HRA examinations, suggesting strong acceptability of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The acceptability of high resolution anoscopy examination in patients attending a tertiary referral centre. De-Masi, A., Davis, E., Cuming, T., et al.[2018]

High-resolution anoscopy (HRA) is generally well tolerated among HIV-infected patients, with 91.7% of surveyed patients reporting acceptable pain levels and all expressing willingness to return for a repeat procedure.

Factors such as pre-existing anal conditions, smoking history, and being female were associated with lower acceptability of HRA, indicating that certain patient characteristics may influence their experience and likelihood of returning for follow-up screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of high-resolution anoscopy for anal cancer screening in HIV-infected patients. Lam, JO., Barnell, GM., Merchant, M., et al.[2019]

High-resolution anoscopy (HRA) is currently used for screening and managing anal squamous dysplasia, particularly in HIV-positive populations where the incidence is highest, but there are no randomized controlled trials or established guidelines for its use.

The understanding of anal dysplasia has evolved from studies on cervical dysplasia, highlighting the importance of human papillomavirus (HPV) in its development and the need for effective screening methods like HRA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

History of High-Resolution Anoscopy. Cho, SD., Groves, E., Lao, VV.[2020]

In a study of 103 patients undergoing high-resolution anoscopy (HRA), 41.7% of the biopsied anal lesions were found to be high-grade anal intraepithelial neoplasia (AIN), indicating a significant prevalence of serious lesions among those screened.

Certain morphological features, such as irregular epithelial patterns and acetic acid-induced whitening, were strongly associated with high-grade AIN, providing a positive predictive value of 68.6% to help guide biopsy decisions during HRA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which lesions should be biopsied during high-resolution anoscopy? Prospective descriptive study of simple morphological criteria. Camus, M., Lesage, AC., Fléjou, JF., et al.[2015]

In a study of 13,552 people with HIV, the introduction of high-resolution anoscopy (HRA) screening showed a significant reduction in the incidence of anal cancer and advanced anal cancer from 2011-2012 compared to earlier years, suggesting potential benefits of the screening program.

While the individual history of screening did not show a statistically significant association with reduced anal cancer rates, the overall trends indicate that HRA screening may be effective in lowering cancer incidence in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Outcomes of a High-Resolution Anoscopy-Based Anal Cancer Screening Program Among People With HIV Enrolled in an Integrated Health Care System. Barnell, GM., Merchant, M., Lam, JO., et al.[2020]

High Resolution Anoscopy (HRA) is a screening method used to detect anal intraepithelial neoplasia (AIN), a precancerous condition that can lead to anal squamous cell carcinoma (ASCC), particularly in immunocompromised patients.

Current literature shows mixed results regarding the effectiveness of HRA in managing AIN, indicating a need for further randomized controlled trials to clarify its benefits compared to other screening techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Update on the Current Role of High Resolution Anoscopy in Patients With Anal Dysplasia. Gudur, A., Shanmuganandamurthy, D., Szep, Z., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient Symptomatology in Anal Dysplasia. [2015]

2. England pubmed.ncbi.nlm.nih.gov

The acceptability of high resolution anoscopy examination in patients attending a tertiary referral centre. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Acceptability of high-resolution anoscopy for anal cancer screening in HIV-infected patients. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

History of High-Resolution Anoscopy. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Which lesions should be biopsied during high-resolution anoscopy? Prospective descriptive study of simple morphological criteria. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Early Outcomes of a High-Resolution Anoscopy-Based Anal Cancer Screening Program Among People With HIV Enrolled in an Integrated Health Care System. [2020]

7. Greece pubmed.ncbi.nlm.nih.gov

An Update on the Current Role of High Resolution Anoscopy in Patients With Anal Dysplasia. [2019]